Shawn and Carrie Pratt of Kingwood, W.Va., with their daughter, Dagen, speak to the media outside a federal health meeting in Washington on Wednesday. Dagen was part of a controversial study of premature babies that has sparked questions about how to inform patients about the risks of medical research.The Associated Press

WASHINGTON — When Dagen Pratt’s parents enrolled their tiny premature baby in a study of oxygen treatment, they didn’t understand it was to test whether one dose works better than another. No one mentioned any risks.

Now 6, Dagen struggles with cerebral palsy, and they wonder: Is that long-ago study to blame?

“Tell me that the Support study did not hurt Dagen in any way,” her father, Shawn Pratt, challenged a government panel on Wednesday as his daughter, dressed in a bright sundress, stood quietly by.

A major controversy has erupted over what sounds like a straightforward question: How much should patients be told about the potential risks before they’re enrolled in certain kinds of medical research?

The issue isn’t about how to study a brand-new, unapproved therapy. All sides agree that those studies must fully inform participants that there’s no guarantee the experiment will work, or even be safe.

Instead, the debate is about one of modern medicine’s dirty little secrets: Doctors frequently prescribe one treatment over another without any evidence to know which option works best. There’s no requirement that they tell their patients when they’re essentially making an educated guess, or that they detail the pros and cons of each choice.

Researchers are supposed to outline all the risks when they study which commonly used option is best. But could that mislead patients into thinking research is riskier than their own doctor’s best guess?

Federal health officials put that question to the public Wednesday, as they debate how strictly to regulate this type of research — a debate sparked by the study of premature babies that included Dagen Pratt of Kingwood, W.Va.

The tiniest preemies face serious risks, including death and disabilities.

Oxygen has been a mainstay of treating them, but doctors didn’t know just how much to use. Too much causes a kind of blindness called retinopathy of prematurity. Too little can cause neurologic damage, even death. So hospitals used a range of oxygen, with some doctors opting for the high end and some for the low.

The Support study, conducted between 2005 and 2009, aimed to settle which end of that range was the best dose. It randomly assigned about 1,300 preemies at 23 hospitals to a lower or higher oxygen dose. To researchers’ surprise, slightly more babies who got the lower dose died, a finding that has led to new standards for the care of preemies.

The problem: A government watchdog agency last spring ruled that researchers violated federal regulations that required them to spell out the risks of the study for parents. Nowhere in the consent forms that parents had to sign was death mentioned.

“This was a very, very important study to do,” Dr. Jerry Menikoff, head of the Office for Human Research Protections, stressed Wednesday. “All we were asking for,” he added, “is a couple of sentences to say there were risks.”

He agreed with consumer advocates that a similar study in New Zealand phrased the issue more appropriately, saying the question is whether the lower dose “is safe and effective in reducing serious vision and lung problems without increasing mortality or neurodevelopmental disability.”

But critics, including the head of the National Institutes of Health, argued that back in 2005, doctors didn’t think the lower dose really posed a survival risk — the question was more about which dose did a good-enough job at saving their vision.

In fact, preemies who didn’t enroll in the study — and got whatever range of oxygen their doctors deemed best — turned out to have a higher risk of death, said NIH Deputy Director Kathy Hudson.

Dr. John Lantos, a bioethicist at Children’s Mercy Hospital in Kansas City, Mo., knows that firsthand. His twin grandsons were born premature but weren’t given an opportunity to enroll in the Support study. One died soon after birth. The other today is thriving but suffered severe retinopathy and has poor vision.

“Nonvalidated therapy is often more dangerous than careful research,” Lantos said, adding that the consent forms should make that clear as well. “Doctors just hate to say they don’t know something. When they do say it, we should listen.”

While the experts debated how to explain research risks, two families who traveled to Washington for the unusual meeting outlined a bigger hurdle: Reeling from the stress of having a vulnerable preemie, they simply didn’t understand that they were participating in an experiment.

They still haven’t been told what dose of oxygen their children received, and it’s impossible to say whether lingering health problems are a consequence of the study or of being extremely premature. Yet, they now wish they hadn’t participated.

“I unknowingly placed my son in harm’s way,” said Sharissa Cook of Attalla, Ala., who wonders if vision problems experienced by her 6-year-old, Dreshan Collins, were caused by the study or from weighing less than 2 pounds at birth. “The only thing a mother wants is for her baby to be well.”

Dagen’s mother, Carrie Pratt, was more blunt with reporters: “Why is omitting information not considered lying?” she said. “We were told they would give her the best care every day.”

This is a horrible, horrible story of parents wanting money out of people that did the best science has to offer. Hope all do not receive a million dollar payout because they are disappointed that science is not God.

The SUPPORT experiment was not the best science has to offer, but the worst, on a par with Mengele Medicine that uses humans as guinea pigs.

The article states "But critics, including the head of the National Institutes of Health, argued that back in 2005, doctors didn't think the lower dose really posed a survival risk _ the question was more about which dose did a good-enough job at saving their vision."

Those critics know this is not true because the researchers themselves had anticipated an increase in death and major brain damage of four percent in the low-oxygen group, and they had expressed in their clinical paper "serious concerns for the safety of the infants in that low-oxygen group." However, they never told the parents about that increased risk and their concern, and the head of the NIH is helping to cover up that lie.

Also, the Deputy Director of the NIH claims that "In fact, preemies who didn't enroll in the study _ and got whatever range of oxygen their doctors deemed best _ turned out to have a higher risk of death." She knows that this is misleading because the analysts at Public Citizen have repeatedly pointed out that the not-enrolled babies had been much sicker to begin with so that they were expected to have a higher rate of death. Omitting this known fact is again lying.

As Mrs. Pratt said correctly, the researchers also lied to her and her husband by omitting to mention the risks. And now they and their accomplices at the NIH are trying to cover up that lie with more lying about allegedly not having known the risks, despite their documented statements to the contrary.

Moreover, since blindness is a non-fatal condition, they had no right to expose the babies to a higher risk of death merely to try and prevent blindness. Knowingly exposing the preemies to that risk of death is premeditated killing, and indeed, the SUPPORT experiment reported 23 "extra" deaths in the suffocation group with less oxygen breathing help.

Such cruel medical experiments have been strictly forbidden ever since the Nuremberg Code which was established to end those Mengele-style medical atrocities, and those modern US researchers as well as their dishonest defenders should be held accountable for their killings and cover-ups.

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